Surgical instrument and method

ABSTRACT

A surgical instrument comprises a member connected with a spinal implant defining an axis. A first image guide is connected with the member and oriented relative to a sensor to communicate a signal representative of a position of the member. A second image guide is connected with the member and oriented to represent an angle measuring a second orientation of the axis relative to a first orientation. Systems, implants and methods are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical devices for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and a method for treating a spine.

BACKGROUND

Spinal pathologies and disorders such as degenerative disc disease, discherniation, osteoporosis, spondylolisthesis, stenosis, scoliosis andother curvature abnormalities, kyphosis, tumor, and fracture may resultfrom factors including trauma, disease and degenerative conditionscaused by injury and aging. Spinal disorders typically result insymptoms including deformity, pain, nerve damage, and partial orcomplete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes fusion, fixation, corpectomy, discectomy, laminectomy andimplantable prosthetics. For example, fusion and fixation treatments maybe performed that employ implants to restore the mechanical supportfunction of vertebrae. Surgical instruments are employed, for example,to prepare tissue surfaces for disposal of the implants. Surgicalinstruments are also employed to engage implants for disposal with thetissue surfaces at a surgical site. This disclosure describes animprovement over these prior technologies.

SUMMARY

In one embodiment, a surgical instrument is provided. The surgicalinstrument comprises a member connected with a spinal implant definingan axis. A first image guide is connected with the member and orientedrelative to a sensor to communicate a signal representative of aposition of the member. A second image guide is connected with themember and oriented to represent an angle measuring a second orientationof the axis relative to a first orientation. In some embodiments,surgical systems, implants and methods are provided.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of the components shown in FIG. 1;

FIG. 3 is a perspective view of the components shown in FIG. 1;

FIG. 4 is a cross-section view of the components shown in FIG.

FIG. 5 is an enlarged break away view of the components shown in FIG. 4;

FIG. 6 is an enlarged break away view of the components shown in FIG. 4;

FIG. 7 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 8 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae;

FIG. 9 is a plan view of components of one embodiment of a surgicalsystem in accordance with the principles of the present disclosuredisposed with vertebrae;

FIG. 10 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 11 is a side view of the components shown in FIG. 10;

FIG. 12 is a perspective view of the components shown in FIG. 10; and

FIG. 13 is a side view of the components shown in FIG. 10.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system are discussed in terms ofmedical devices for the treatment of musculoskeletal disorders and moreparticularly, in terms of a surgical system for preparing a surgicalsite, and a method for treating a spine. In some embodiments, thesurgical system includes a surgical instrument having an image guide,such as, for example, a surgical navigation tracker.

In some embodiments, the surgical system includes a surgical instrument,such as, for example, an inserter employed with a selected spinalimplant, such as, for example, an interbody implant, which is connectedto the surgical instrument. In some embodiments, the surgical instrumentincludes an image guide, such as, for example, a rotational gauge. Insome embodiments, the surgical instrument includes a clutch inserterwith a rotational gauge.

In some embodiments, the spinal implant includes an intervertebralspacer. In some embodiments, the surgical system is employed with amethod that includes manipulation, movement, translation and/or rotationof the implant with an intervertebral disc space. In some embodiments,the spinal implant includes markers for positioning and rotation. Insome embodiments, the spinal implant includes a loop implant.

In some embodiments, the surgical instrument has an instrument trackerand a distal/working end. In some embodiments, the surgical trackerprovides indicia and/or display of a location of the surgical instrumentand its distal/working end. In some embodiments, the surgical systemincludes a surgical instrument having one or more image guides, whichinclude one or more fiducial markers. In some embodiments, the fiducialmarker includes a single ball-shaped marker. In some embodiments, theimage guide is disposed adjacent a proximal end of the surgicalinstrument. In some embodiments, the image guide is attached to alongitudinal element of the surgical instrument that moves distally in alinear fashion relative to the surgical instrument and rotates theimplant in the disc space. In some embodiments, the image guide providesindicia and/or display of a precise linear position of the image guideon the surgical instrument. In some embodiments, this configurationprovides indicia and/or display of an amount of manipulation, movement,translation and/or rotation of the implant with tissue, such as, forexample, an intervertebral space.

In some embodiments, the surgical system includes a surgical instrumenthaving one or more image guides, which include a tracker that provideslocation of a surgical instrument in three dimensions, and a trackerthat provides location of the surgical instrument and/or a spinalimplant in two dimensions, such as, for example, a selected plane. Insome embodiments, this configuration provides indicia and/or display ofimplant position corresponding to an amount of manipulation, movement,translation and/or rotation of the implant with tissue, such as, forexample, an intervertebral space. In some embodiments, the surgicalsystem includes a surgical instrument that comprises an inserteremployed with a method for delivering an interbody spacer into anintervertebral disc space. In some embodiments, the method includes thestep of manipulating, moving, translating and/or rotating the interbodyspacer in a precise amount upon selected disposal of the interbodyspacer in the intervertebral disc space.

In some embodiments, the surgical system includes a surgical instrumentcomprising a navigation compatible implant inserter. In someembodiments, the surgical system includes a surgical instrument havingone or more image guides, which provide position and rotation indiciaand/or display of an interbody implant via a camera sensor and acomputer display screen. In some embodiments, the surgical systemincludes a surgical inserter that has two image guide arrays. In someembodiments, the image guide arrays interact with a navigation enabledcamera sensor to provide imaging during insertion and rotation of aninterbody implant. In some embodiments, the image guide arrays include alarge top array used for insertion tracking of the surgical instrument,and may be used on either side of a patient. In some embodiments, thelarge top array is indexable for use on either side of the patient.

In some embodiments, the image guide arrays include a lower array, whichprovides location of the surgical instrument and/or a spinal implant. Insome embodiments, the lower array includes a lower gauge shaft thattranslates in a linear fashion in direct contact with the implant anddirectly rotates a graduated gauge to provide rotational position of theimplant. In some embodiments, the image guide arrays include the largetop array and/or the lower array to increase the accuracy of implantplacement.

In some embodiments, the surgical instrument includes a surgicallynavigated instrument, such as, for example, drills, drivers, and taps,which freely rotate about a centerline axis. In some embodiments, thesurgical instrument includes a navigation tracker that is opticallytracked and requires a line-of-sight view to a sensor, such as, forexample, a camera. In some embodiments, the surgical system includes anavigation tracker attached to a surgical instrument and is disposed ina direct line of sight of a sensor, which includes one or more cameras.In some embodiments, the surgical system includes an O-arm medicalimaging device that digitally captures images of an anatomy. In someembodiments, the tracker communicates with a surgical navigation systemto determine and/or display surgical instrument positioning relative tothe anatomy.

In some embodiments, one or all of the components of the surgical systemmay be disposable, peel pack and/or pre packed sterile devices. One orall of the components of the surgical system may be reusable. Thesurgical system may be configured as a kit with multiple sized andconfigured components.

In some embodiments, the surgical system of the present disclosure maybe employed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the surgical system of the presentdisclosure may be employed with other osteal and bone relatedapplications, including those associated with diagnostics andtherapeutics. In some embodiments, the surgical system may bealternatively employed in a surgical treatment with a patient in a proneor supine position, and/or employ various surgical approaches to thespine, including anterior, posterior, posterior mid-line, lateral,postero-lateral, and/or antero-lateral approaches, and in other bodyregions. The surgical system of the present disclosure may also bealternatively employed with procedures for treating the lumbar,cervical, thoracic, sacral and pelvic regions of a spinal column. Thesurgical system of the present disclosure may also be used on animals,bone models and other non-living substrates, such as, for example, intraining, testing and demonstration.

The surgical system of the present disclosure may be understood morereadily by reference to the following detailed description of theembodiments taken in connection with the accompanying drawing figures,which form a part of this disclosure. It is to be understood that thisapplication is not limited to the specific devices, methods, conditionsor parameters described and/or shown herein, and that the terminologyused herein is for the purpose of describing particular embodiments byway of example only and is not intended to be limiting. In someembodiments, as used in the specification and including the appendedclaims, the singular forms “a,” “an,” and “the” include the plural, andreference to a particular numerical value includes at least thatparticular value, unless the context clearly dictates otherwise. Rangesmay be expressed herein as from “about” or “approximately” oneparticular value and/or to “about” or “approximately” another particularvalue. When such a range is expressed, another embodiment includes fromthe one particular value and/or to the other particular value.Similarly, when values are expressed as approximations, by use of theantecedent “about,” it will be understood that the particular valueforms another embodiment. It is also understood that all spatialreferences, such as, for example, horizontal, vertical, top, upper,lower, bottom, left and right, are for illustrative purposes only andcan be varied within the scope of the disclosure. For example, thereferences “upper” and “lower” are relative and used only in the contextto the other, and are not necessarily “superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. As used in the specification andincluding the appended claims, the term “tissue” includes soft tissue,ligaments, tendons, cartilage and/or bone unless specifically referredto otherwise.

The following discussion includes a description of a surgical systemincluding a surgical instrument, related components and methods ofemploying the surgical system in accordance with the principles of thepresent disclosure. Alternate embodiments are disclosed. Reference ismade in detail to the exemplary embodiments of the present disclosure,which are illustrated in the accompanying figures. Turning to FIGS. 1-7,there are illustrated components of a surgical system 10.

The components of surgical system 10 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites. For example, the components of surgical system 10,individually or collectively, can be fabricated from materials such asstainless steel alloys, aluminum, commercially pure titanium, titaniumalloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chromealloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyimide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

Various components of surgical system 10 may have material composites,including the above materials, to achieve various desiredcharacteristics such as strength, rigidity, elasticity, compliance,biomechanical performance, durability and radiolucency or imagingpreference. The components of surgical system 10, individually orcollectively, may also be fabricated from a heterogeneous material suchas a combination of two or more of the above-described materials. Thecomponents of surgical system 10 may be monolithically formed,integrally connected or include fastening elements and/or instruments,as described herein.

Surgical system 10 is employed, for example, with a fully open surgicalprocedure, a minimally invasive procedure including percutaneoustechniques, and mini-open surgical techniques to deliver and introduceinstrumentation and/or a spinal implant, such as, for example, aninterbody implant, at a surgical site of a patient, which includes, forexample, a spine having vertebrae V, as shown in FIGS. 8 and 9. In someembodiments, the spinal implant can include one or more components ofone or more spinal constructs, such as, for example, cages, spacers,vertebral devices, bone fasteners, spinal rods, connectors and/orplates.

Surgical system 10 comprises a surgical instrument, such as, forexample, an inserter 12. Inserter 12 includes a member, such as, forexample, a body 14 that defines a longitudinal axis A1. Body 14 extendsbetween an end 16 and an end 18. Body 14 includes an outer sleeve 20. Insome embodiments, one or more portions of outer sleeve 20 may betubular, solid and/or define cavities for disposal of components ofinserter 12.

Outer sleeve 20 includes a handle 22 and a shaft 24. Handle 22 extendsbetween an end 26 and an end 28. In some embodiments, handle 22 may havealternate cross section configurations, such as, for example, oval,oblong, triangular, square, hexagonal, polygonal, irregular, uniform,non-uniform and/or tapered. In some embodiments, handle 22 may beassembled with shaft 24, as described herein. In some embodiments,handle 22 may be monolithically formed with shaft 24. In someembodiments, handle 22 may be disposed at alternate orientationsrelative to shaft 24, such as, for example, transverse, parallel,perpendicular and/or other angular orientations such as acute or obtuse,co-axial, offset, and/or staggered.

Handle 22 includes a surface 30 that defines a cavity 32. Cavity 32 isconfigured for disposal of a longitudinal member, such as, for example,a shaft 34. Shaft 34 is configured to connect a spinal implant 150 withinserter 12, as described herein. Handle 22 is configured to facilitatemanipulating, moving, translating and/or rotating spinal implant 150, asdescribed herein. Handle 22 includes an actuator that includes apivoting grip 40 and a knob 60, as described herein.

Grip 40 extends between an end 42 and an end 44. In some embodiments,grip 40 is ergonomically designed to be held in a plurality oforientations. In some embodiments, grip 40 includes indents configuredto facilitate manipulation of grip 40. Grip 40 is connected with handle22 at end 42 by a pin 46. End 44 includes a flange 48 configured tofacilitate locking and unlocking of grip 40 relative to handle 22, asdescribed herein.

Grip 40 is configured to rotate and/or pivot about pin 46 relative toaxis A1. Grip 40 rotates about pin 46 between a locking orientation, asshown in FIG. 2, and a non-locking orientation, as shown in FIG. 3, ofgrip 40 with shaft 34. Locking of grip 40 resists and/or preventstranslation of shaft 34, for example, such that spinal implant 150 isdisposed in a selected and fixed position relative to end 18, asdescribed herein. Rotating grip 40 into a non-locking orientation allowsfor movement and/or translation of shaft 34 relative to body 14 tofacilitate movement and/or rotation of spinal implant 150 relative toend 18, as described herein. In some embodiments, grip 40 may be rotatedthrough an angular range of 0-90 degrees relative to axis A1. In someembodiments, grip 40 may have various configurations, such as, forexample, solid, tubular, arcuate, offset, staggered, uniform andnon-uniform.

In some embodiments, grip 40 includes a biasing member, such as, forexample, a torsion spring 49 disposed about pin 46, as shown in FIG. 4.Spring 49 includes legs that are connected with grip 40 and body 14. Assuch, spring 49 applies a biasing force to grip 40 to urge grip 40 intothe non-locking orientation, as described herein. Grip 40 is manipulableto overcome the biasing force of spring 49 to pivot and/or rotate grip40 for disposal in the locking orientation, as described herein. In someembodiments, grip 40 may be manually manipulable without a biasingmember.

In some embodiments, the biasing member as described herein comprises aspring, a conical spring washer, a disc spring, a Belleville spring, acupped spring washer, a coil spring, an elastomeric member, a clip, aleaf spring, gravity induced configuration, pneumatic configuration,hydraulic configuration and/or manual lever. In some embodiments, thebiasing member may have a semi-rigid, rigid or elastic configuration,and/or have elastic properties, such as the elastic propertiescorresponding to the material examples described above, such that thebiasing member provides a selective amount of movement between selectedpositions and orientations. In some embodiments, the biasing member mayinclude a plurality of separately attachable or connectable portions orsections, such as bands or loops, or may be monolithically formed as asingle continuous element. In some embodiments, the biasing memberincludes an axial element, such as, for example, a flexible shaft. Insome embodiments, the biasing member has a solid disc or sphere shape.

Handle 22 includes a lock, such as, for example, a collar 50 configuredto engage grip 40 for disposal in a locking orientation and anon-locking orientation relative to handle 22. Collar 50 includes acavity, such as, for example, a cutout 52. Cutout 52 is configured tofacilitate movement of grip 40 to a non-locking orientation, asdescribed herein, Collar 50 is rotatable, in a clockwise direction and acounter-clockwise direction, between a locked orientation, as shown inFIG. 1, such that flange 48 is disposed within collar 50 and collar 50resists and/or prevents pivoting of grip 40 relative to handle 22, and anon-locked orientation, as shown in FIG. 3, such that flange 48 isaligned with cutout 52 for movement therethrough and relative to handle22. Alignment of cutout 52 with flange 48 allows grip 40 to disengagefrom collar 50 by passing through cutout 52. Disengagement of grip 40from collar 50 allows for pivoting of grip 40 relative to handle 22.Grip 40 is configured to resist and/or prevent rotation of spinalimplant 150 during a surgical procedure, as described herein.

Knob 60 is connected with handle 22 at end 26. Knob 60 is rotatable, ina clockwise direction and a counter-clockwise direction, to facilitatemovement and/or translation of shaft 34 for moving and/or rotatingspinal implant 150 to a selected orientation, as described herein. Shaft34 extends between an end 62 and an end 64.

End 62 is engageable with knob 60 such that rotation of knob 60 causesshaft 34 to engage spinal implant 150 for movement and/or rotationrelative to end 18. In some embodiments, shaft 34 is connected with knob60 by a pin. In some embodiments, shaft 34 is connected with knob 60 bya threaded engagement. Shaft 34 includes a surface 63 that defines acircumferential flange 65. Flange 65 is configured for engagement with aflange 148 in the locking orientation of grip 40 to resist and/orprevent translation of shaft 34 relative to handle 22. When engaged in alocking orientation of grip 40, flange 148 applies a force to flange 65in a mating engagement to apply a force and/or pressure to shaft 34.This force fixes position of shaft 34 relative to handle 22 and/or formsa pressure fit between end 18 and spinal implant 150. This configurationresists and/or prevents movement and/or rotation of spinal implant 150relative to end 18. Flange 148 disengages from flange 65 for disposal ofshaft 34 in a non-locked orientation, Disengagement of flange 148 fromflange 65 releases the mating engagement and/or pressure fit between end18 and spinal implant 150 to allow movement and/or rotation of spinalimplant 150 relative to end 18. In some embodiments, grip 40 isselectively disposed in the locking and non-locking orientation toselectively fix and manipulate, move, translate, rotate and/or adjustposition of spinal implant 150 relative to end 18 such that locking ofgrip 40 can be applied, released and/or re-applied for one or aplurality of iterations for positioning of spinal implant 150 withtissue. In some embodiments, grip 40 is selectively disposed in thelocking and non-locking orientation to selectively fix and adjustposition of spinal implant 150 in an angular range of 0 through 360degrees relative to and about end 18. In some embodiments, grip 40 isselectively disposed in the locking and non-locking orientation toselectively fix and manipulate, move, translate, rotate and/or adjustposition of spinal implant 150 relative to end 18 in a range of movementof spinal implant 150 between an insertion or delivery orientation, forexample, as shown and described herein with regard to FIG. 1 and animplant orientation, as shown and described herein with regard to FIG.3.

End 64 includes a surface 66 configured for mating engagement with amovable pin 156 disposed with spinal implant 150, as described herein.In some embodiments, end 64 is configured for threaded engagement withpin 156 upon actuation of knob 60. Actuation of knob 60 causes shaft 34to draw spinal implant 150 into engagement with end 18 to fix spinalimplant 150 with end 18 for delivery to a surgical site, as describedherein. In some embodiments, surface 66 may have alternate surfaceconfigurations for mating engagement with a surface of spinal implant150, such as, for example, grooved, rough, dimpled, polished, texturedand/or a drive or socket, which may include a square, triangular,hexagonal, polygonal, star, torx or hexalobe cross section.

In some embodiments, handle 22 includes a mating cavity 68 disposed atend 28, as shown in FIG. 5. In some embodiments, mating cavity 68 mayinclude a square, triangular, hexagonal, polygonal, star, torx orhexalobe cross section configured engage a correspondingly shapedportion of a surface that defines a mating surface 92 disposed withshaft 24, as described herein.

Body 14 is configured for connection with an image guide, which includesa navigation component 70, as described herein. Navigation component 70is configured to generate a signal representative of a position ofinserter 12. In some embodiments, an image guide as described herein mayinclude human readable visual indicia, human readable tactile indicia,human readable audible indicia, one or more components having markersfor identification under x-ray, fluoroscopy, CT or other imagingtechniques, at least one light emitting diode, a wireless component, awired component, a near field communication component and/or one or morecomponents that generate acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals.

Navigation component 70 includes a collar 72 configured for disposalwith a portion of body 14. In some embodiments, collar 72 is fixed withbody 14. In some embodiments, collar 72 is rotatable relative to body 14about axis A1. In some embodiments, collar 72 is connected with body 14via friction fit, pressure fit, interlocking engagement, matingengagement, dovetail connection, hook and loop closure, clips, barbs,tongue in groove, threaded, magnetic, key/keyslot, drill chuck and/oradhesive.

Collar 72 includes a post 80 extending therefrom. Post 80 defines anaxis X1. Post 80 extends perpendicular to axis A1 and is rotatable withcollar 72 about axis A1. In some embodiments, axis X1 may be disposed atalternate orientations relative to axis A1, such as, for example,parallel, transverse and/or other angular orientations, such as, acuteor obtuse.

Navigation component 70 includes a tracking device having an emitterarray 82 that is connected to collar 72 via post 80. In someembodiments, post 80 includes a cavity 81. In some embodiments, cavity81 is configured to receive a threaded screw 83 configured to connectemitter array 82 with collar 72. Emitter array 82 is rotatable withcollar 72 about axis A1. In some embodiments, emitter array 82 may bedisposed at alternate orientations relative to axis A1, such as, forexample, parallel, perpendicular, transverse and/or other angularorientations, such as, acute or obtuse.

Emitter array 82 is configured for generating a signal to a sensor array202, as shown in FIG. 7 and described herein, representing athree-dimensional spatial position and/or a trajectory of inserter 12and/or spinal implant 150 relative to a portion of a patient's anatomyand/or a depth of inserter 12 and/or spinal implant 150 within thepatient's anatomy for display on a monitor. Emitter array 82 includesfour spaced apart arms having a substantially X-shape. Emitter array 82includes markers, such as, for example, fiducials 84. Fiducials 84appear in the image produced by a surgical navigation system 200 ofsurgical system 10 for use as a point of reference or a measure. Emitterarray 82 generates signals representing the position of various bodyreference points of the patient's anatomy. In some embodiments,fiducials 84 include at least one light emitting diode. In someembodiments, fiducials 84 may include other tracking devices capable ofbeing tracked by sensor array 202, such as, for example, a trackingdevice that actively generates acoustic signals, magnetic signals,electromagnetic signals and/or radiologic signals. In some embodiments,fiducials 84 may be removably attached to emitter array 82. In someembodiments, one or more of fiducials 84 each include a singleball-shaped marker.

Shaft 24 extends distally from handle 22 and includes end 18. Shaft 24includes an end 90. End 90 includes cavity 92 configured for a matingengagement with mating surface 68. In some embodiments, cavity 92 mayhave various cross-section configurations, such as, for example, oval,oblong, triangular, rectangular, square, polygonal, irregular, uniform,non-uniform, variable, tubular and/or tapered.

Shaft 24 includes a surface 94 that defines a cavity, such as, forexample, an axial channel 96. Channel 96 extends between an end 98 andan end 100, Channel 96 is configured for disposal of a longitudinalelement, such as, for example, a rod 102. Rod 102 extends within channel96 and includes an end 104 and an end 106 disposed adjacent end 18 andspinal implant 150 when attached with inserter 12.

Rod 102 is configured for translation relative to shaft 24 as spinalimplant 150 is moved and/or rotated for positioning with tissue toprovide indicia and/or display of an amount of manipulation, movement,translation and/or rotation of spinal implant 150 with tissue, such as,for example, an intervertebral space, as described herein. In someembodiments, rod 102 may have alternate cross section configurations,such as, for example, oval, oblong, triangular, square, hexagonal,polygonal, irregular, uniform, non-uniform and/or tapered.

In some embodiments, rod 102 includes a biasing member, such as, forexample, a coil spring 110 mounted within a cavity of rod 102 andengageable with body 14. Spring 110 applies a biasing force to rod 102to urge rod 102 into the insertion or delivery orientation, as describedherein. With end 18 connected with spinal implant 150 in the insertionor delivery orientation, and handle 22 and shaft 34 disposed in thelocking orientation, as described herein, spinal implant 150 is fixedwith inserter 12. End 18 is fixed with spinal implant 150 and end 106engages a surface of spinal implant 150 to provide indicia and/or adisplay of end 18 and/or spinal implant 150, as described herein.

End 104 includes an image guide 120. Image guide 120 includes an anglegauge 122 and a navigation component 180, as described herein. Gauge 122measures a change in angle between an orientation, for example, adelivery orientation, as shown in FIG. 8, and an orientation, forexample, an implant orientation, as shown in FIG. 9, as describedherein. Image guide 120 represents and displays an angular measurementof the change in angle between selected relative orientations of spinalimplant 150.

Gauge 122 extends between an end 124 and an end 126, as shown in FIG. 5.Gauge 122 rotates relative to shaft 24, as described herein. End 124includes a ring 128, which is disposed about a pivot or pin 130 andconfigured to facilitate rotation of gauge 122 relative to shaft 24. Insome embodiments, pin 130 is fixed with rod 102. In some embodiments,ring 128 is disposed with pin 130 in a substantially frictionlessengagement to facilitate rotation of gauge 122 relative to shaft 24. Insome embodiments, pin 130 is fixed with gauge 122 and rotatable relativeto shaft 24 such that gauge 122 rotates relative to shaft 24. Gauge 122pivots about pin 130 via ring 128 in response to translation of rod 102such that gauge 122 rotates about pin 130, as described herein.

Gauge 122 includes arcuate sections 132, 134. Sections 132, 134 aredisposed in a spaced apart relation. Section 132 includes a surface 136that define a track 138. Section 134 includes a surface 140 that definesa track 142. Tracks 138, 142 are configured for moveable disposal of amember, such as, for example, a marker 144 disposed with rod 102, asshown in FIGS. 2 and 3.

In some embodiments, marker 144 is displaced and/or translated axiallywith rod 102 from an initial orientation, for example the deliveryorientation of spinal implant 150, which indicates a resting, zero angleor calibration orientation of marker 144 and/or gauge 122. From theinitial orientation, rod 102 engages spinal implant 150 to manipulate,move, translate and/or rotate spinal implant 150 such that marker 144 isdisplaced and/or translated axially with rod 102. In some embodiments,gauge 122 and/or marker 144 rotate about pin 130 relative to shaft 24 tomeasure a change in an angular orientation of gauge 122 and spinalimplant 150 relative to inserter 12 and/or tissue, as described herein.In some embodiments, rod 102 translates in a proximal direction toovercome the biasing force of spring 110. In some embodiments, rod 102may translate in a proximal direction and a distal direction in theimplant orientation for positioning spinal implant 150 with tissue. Insome embodiments, such translation causes gauge 122 to rotate from restand/or equilibrium and a restoring force due to gravity is subjected togauge 122. Marker 144 causes gauge 112 to pivot or rotate about pin 130such that marker 144 moves along tracks 138, 142 to indicate a measuredangle of an implant orientation of spinal implant 150 relative to theinitial orientation. In some embodiments, gauge 122 is rotated relativeto marker 144 such that marker 144 is aligned with indicia 146 torepresent and display an angular measurement of the angular differenceof spinal implant 150 during insertion. In some embodiments; section 132and/or section 134 include indicia 146 having information representingand displaying an angular measurement, as described herein. Pin 130connects gauge 122 and marker 144 to shaft 24.

In some embodiments, indicia 146 includes graduated markings disposedalong a surface of section 132 and/or section 134. In some embodiments,the markings display, represent and/or provide information relating toan angular range for measuring, selecting, adjusting and/or displayingan angle measured by gauge 122, as described herein. In someembodiments, the markings may include bi-laterally disposed groovesequidistantly spaced apart and corresponding to measured angularincrements of indicia 146.

In some embodiments, indicia 146 includes markings that may be disposedin increments of 10 angular degrees. In some embodiments, indicia 146may include an analog, such as, for example, a dial with a numericalindicator of angle and/or digital display, such as, for example, LEDand/or LCD. In some embodiments, indicia 146 include human readablevisual indicia, such as, for example, a label, color coding,alphanumeric characters or an icon. In some embodiments, indicia 146include human readable tactile indicia, such as, for example, raisedportions, lowered portions or Braille. In some embodiments, indicia 146is a printed or written item in combination with a slot or groove,whereby the printed or written item is placed in the slot or groove todisplay information. In some embodiments, indicia 146 may be applied asan adhesive.

In some embodiments, gauge 122 and/or marker 144 and/or indicia 146include radiolucent materials such as polymers. Radiomarkers may beincluded for identification under x-ray, fluoroscopy, CT or otherimaging techniques. In some embodiments, navigation component 180 isconfigured to generate a signal representative of an angular position ofend 106, end 18 and/or spinal implant 150, In some embodiments,navigation component 180 is configured to generate the signal as spinalimplant 150 rotates. Navigation component 180 includes a fiducial 182.Fiducial 182 appears in an image produced by surgical navigation system200 for use as a point of reference or a measure. Fiducial 182 generatessignals representing positioning of gauge 122 and an angular position ofspinal implant 150. In some embodiments, fiducial 182 generates signalsrepresenting a position of spinal implant 150 being rotated to aselected orientation with tissue. In some embodiments, fiducial 182generates signals representing a selected plane of a body, such as, forexample, a transverse plane. In some embodiments, fiducial 182 includesat least one light emitting diode. In some embodiments, fiducial 182 mayinclude other tracking devices capable of being tracked by sensor array202, such as, for example, a tracking device that actively generatesacoustic signals, magnetic signals, electromagnetic signals, radiologicsignals. In some embodiments, fiducial 182 may be removably attached torod 102. In some embodiments, fiducial 182 may include a singleball-shaped marker. In some embodiments, fiducial 182 may include one ora plurality of markers.

Navigation component 180 is disposed with gauge 122 and is rotatable toprovide indicia and/or display the angular orientation and/or atrajectory of spinal implant 150 relative to inserter 12, a portion of apatient's anatomy and/or a depth of end 18 and/or spinal implant 150within the patient's anatomy. Rod 102 is oriented with shaft 24 andengageable with a surface of spinal implant 150 between a proximalposition and a distal position relative to body 14 such that fiducial182 provides the angular indicia and/or display of spinal implant 150.

End 106 is configured for disposal adjacent a surface of spinal implant150 such that rotation of spinal implant 150 causes rod 102 to translatewithin channel 96, as shown in FIGS. 8 and 9. Translation of rod 102causes fiducial 182 to rotate to indicate position, movement and/orrotation of spinal implant 150.

In some embodiments, the proximal position of rod 102 corresponds tospinal implant 150 being connected with end 18 and disposed in aninsertion or delivery orientation, as shown in FIG. 8. In someembodiments, in the insertion or delivery orientation, spinal implant150 is disposed in axial alignment with shaft 24. In some embodiments,the distal position of rod 102 corresponds to spinal implant 150 beingconnected with end 18 and disposed in an implant orientation, as shownin FIG. 9. In some embodiments, the two-dimensional spatial positionand/or trajectory includes a plane of the patient's anatomy, such as,for example, a transverse plane.

Spinal implant 150 includes a vertebral engaging surface 152 and avertebral engaging surface 154. In some embodiments, the cross-sectionalgeometry of spinal implant 150 may have various configurations, such as,for example, round, oval, oblong, triangular, polygonal having planar orarcuate side portions, irregular, uniform, non-uniform, consistent,variable, horseshoe shape, U-shape or kidney bean shape. In someembodiments, surfaces 152, 154 may be smooth, even, rough, textured,porous, semi-porous, dimpled and/or polished.

In some embodiments, spinal implant 150 includes a cavity configured fordisposal of a pin 156 to facilitate rotating and/or pivoting of spinalimplant 150 relative to end 18. Pin 156 includes a surface configuredfor engagement with end 64 of shaft 34. In some embodiments, pin 156includes a threaded inner surface that mates with threads 66 tofacilitate connection of spinal implant 150 with inserter 12 forpositioning of spinal implant 150 with tissue.

In some embodiments, spinal implant 150 is rotatable relative to pin 156through a selected angular range. In some embodiments, spinal implant150 is selectively rotatable relative to pin 156. In some embodiments,spinal implant 150 is passively rotatable relative to pin 156 such thatmanipulation of inserter 12 connected with spinal implant 150 duringinsertion of spinal implant 150 with a vertebral space causes spinalimplant 150 to rotate relative to pin 156 due to engagement with end 18and resistance of tissue.

Inserter 12 is configured for disposal adjacent a surgical site suchthat navigation component 70 and/or navigation component 180 areoriented relative to sensor array 202 to facilitate communicationbetween navigation component 70 and/or navigation component 180, andsensor array 202 during a surgical procedure, as described herein. Insome embodiments, sensor array 202 receives signals from navigationcomponent 70 to provide a three-dimensional spatial position and/or atrajectory of inserter 12 and/or spinal implant 150 relative to aportion of a patient's anatomy and/or a depth of inserter 12 and/orspinal implant 150 within the patient's anatomy for display on amonitor. In some embodiments, sensor array 202 receives signals fromnavigation component 180 disposed with gauge 122 to provide an angularposition of end 106, end 18 and/or spinal implant 150. See, for example,similar surgical navigation components and their use as described inU.S. Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entire contents ofeach of these references being incorporated by reference herein.

Surgical navigation system 200 is configured for acquiring anddisplaying medical imaging, such as, for example, x-ray imagesappropriate for a given surgical procedure, as shown in FIG. 7. In someembodiments, pre-acquired images of a patient are collected. In someembodiments, surgical navigation system 200 can include an O-arm®imaging device 204 sold by Medtronic Navigation, Inc. having a place ofbusiness in Louisville, Colo., USA. Imaging device 204 may have agenerally annular gantry housing that encloses an image capturingportion 208.

In some embodiments, image capturing portion 208 may include an x-raysource or emission portion and an x-ray receiving or image receivingportion located generally or as practically possible 180 degrees fromeach other and mounted on a rotor (not shown) relative to a track ofimage capturing portion 208, Image capturing portion 208 can be operableto rotate 360 degrees during image acquisition. Image capturing portion208 may rotate around a central point or axis, allowing image data ofthe patient to be acquired from multiple directions or in multipleplanes. Surgical navigation system 200 can include those disclosed inU.S. Pat. Nos. 8,842,893, 7,188,998; 7,108,421; 7,106,825; 7,001,045;and 6,940,941; the entire contents of each of these references beingincorporated by reference herein.

In some embodiments, surgical navigation system 200 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 208 can beprecisely known relative to any other portion of imaging device 204. Insome embodiments, a precise knowledge of the position of image capturingportion 208 can be used in conjunction with a tracking system 210 todetermine the position of image capturing portion 208 and the image datarelative to the patient.

Tracking system 210 can include various portions that are associated orincluded with surgical navigation system 200. In some embodiments,tracking system 210 can also include a plurality of types of trackingsystems, such as, for example, an optical tracking system that includesan optical localizer, such as, for example, sensor array 202 and/or anEM tracking system that can include an EM localizer. Various trackingdevices can be tracked with tracking system 210 and the information canbe used by surgical navigation system 200 to allow for a display of aposition of an item, such as, for example, a patient tracking device214, an imaging device tracking device 216, and an instrument trackingdevice, such as, for example, navigation components 70, 180, to allowselected portions to be tracked relative to one another with theappropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation,Inc, having a place of business in Louisville, Colo. Exemplary trackingsystems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820,5,592,939, the entire contents of each of these references beingincorporated by reference herein.

Fluoroscopic images taken are transmitted to computer 218 where they maybe forwarded to surgical navigation computer 220. Image transfer may beperformed over a standard video connection or a digital link includingwired and wireless. Computer 220 provides the ability to display, viamonitor 222, as well as save, digitally manipulate, or print a hard copyof the received images. In some embodiments, images may also bedisplayed to the surgeon through a heads-up display.

In some embodiments, surgical navigation system 200 provides forreal-time tracking of inserter 12 and spinal implant 150. Sensor array202 is located in such a manner to provide a clear line of sight withnavigation components 70, 180, as described herein. In some embodiments,navigation components 70, 180 communicate with sensor array 202 viainfrared technology. Sensor array 202 is coupled to computer 220, whichmay be programmed with software modules that analyze signals transmittedby sensor array 202 to determine the position of each object in adetector space. A processor sends the information to monitor 222, whichprovides a visual representation of the position of inserter 12 andspinal implant 150 relative to the patient's anatomy to allow themedical practitioner to move inserter 12 and spinal implant 150 to adesired location within the patient's anatomy.

In assembly, operation and use, surgical system 10, similar to thesystems and methods described herein, is employed with a surgicalprocedure for treatment of a spinal disorder affecting a section of aspine of a patient, as discussed herein. For example, the components ofsurgical system 10 can be used with a surgical procedure for treatmentof a condition or injury of an affected section of the spine includingvertebrae V, as shown in FIGS. 8 and 9. In some embodiments, one or allof the components of surgical system 10 can be delivered or implanted asa pre-assembled device or can be assembled in situ. Surgical system 10may be completely or partially revised, removed or replaced.

The components of surgical system 10 can be employed with a surgicaltreatment of an applicable condition or injury of an affected section ofa spinal column and adjacent areas within a body, such as, for example,vertebrae V. In some embodiments, the components of surgical system 10may be employed with one or a plurality of vertebra, such as, forexample, vertebra V1 and vertebra V2, To treat a selected section ofvertebrae V, a medical practitioner obtains access to a surgical siteincluding vertebrae V in any appropriate manner, such as throughincision and retraction of tissues. In some embodiments, the componentsof surgical system 10 can be used in any existing surgical method ortechnique including open surgery, mini-open surgery, minimally invasivesurgery and percutaneous surgical implantation, whereby vertebrae V areaccessed through a mini-incision, or sleeve that provides a protectedpassageway to the area. Once access to the surgical site is obtained,the particular surgical procedure can be performed for treating thespine disorder.

An incision is made in the body of a patient and a cutting instrument(not shown) creates a surgical pathway for delivery of components ofsurgical system 10 including inserter 12, as described herein, adjacentan area within the patient's body, such as, for example, vertebra V1 andvertebra V2. In some embodiments, a preparation instrument (not shown)is employed to remove disc tissue, fluids, adjacent tissues and/or bone,and scrape and/or remove tissue from endplate surfaces of vertebra V1and/or endplate surface of vertebra V2. In some embodiments, the size ofspinal implant 150 is selected after trialing. In some embodiments,spinal implant 150 is visualized by fluoroscopy and oriented beforeintroduction into the vertebral space.

Inserter 12 is connected with spinal implant 150, as described herein,for disposal in an insertion or delivery orientation, as describedherein. Grip 40 is initially disposed in the non-locking orientation andmanipulated for rotation about pin 46 to the locking orientation, asshown in FIG. 8 and described herein. Collar 50 is disposed in thelocked orientation, as described herein. Knob 60 is rotated causingshaft 34 to engage pin 156 to connect spinal implant 150 with inserter12, as described herein, and draw ends 18, 106 into engagement withspinal implant 150.

Spinal implant 150 is disposed in a selected and fixed position relativeto end 18 such that spinal implant 150 is axially aligned with shaft 24.Inserter 12 is manipulated to deliver spinal implant 150 to thevertebral space between vertebrae V1, V2. Sensor array 202 receivessignals from navigation component 70 to provide a three-dimensionalspatial position and/or a trajectory of inserter 12 and/or spinalimplant 150 relative to the vertebral space between vertebrae V1, V2and/or a depth of inserter 12 and/or spinal implant 150 within thevertebral space for display on monitor 222.

Inserter 12 selectively disposes spinal implant 150 with the vertebralspace between vertebrae V1, V2, as shown in FIG. 8. With end 18connected with spinal implant 150 in the insertion or deliveryorientation, end 106 engages a surface of spinal implant 150 to providethe indicia and/or display of end 18 and/or spinal implant 150 inconnection with fiducial 182, as described herein. Collar 50 is rotatedto the non-locked orientation, as described herein. Grip 40 is releasedfor rotation about pin 46 to the non-locking orientation, as shown inFIG. 9 and described herein. The pressure fit between ends 18, 106 isreleased and spinal implant 150 is movable and/or rotatable relative toend 18, 106.

Manipulation of inserter 12 causes spinal implant 150 to move and/orrotate about pin 156, as described herein, into position with thevertebral space between vertebrae V1, V2. As spinal implant 150 ismanipulated, moved, translated and/or rotated in the implant orientationfor positioning spinal implant 150 with the vertebral space betweenvertebrae V1, V2, spinal implant 150 is engaged with rod 102 such thatrod 102 translates in a proximal direction. Such translation causesgauge 122 to rotate about pin 130 to align marker 144 with indicia 146to indicate a measured angle of the implant orientation for positioningspinal implant 150 with the vertebral space between vertebrae V1, V2relative to the insertion or delivery orientation, as described herein.

In some embodiments, indicia 146 is visibly read by a practitionerviewing gauge 122. In some embodiments, sensor array 202 receivessignals from navigation component 180 to provide an angular position ofend 106, end 18 and/or spinal implant 150, for example, within atransverse plane of vertebrae V. In some embodiments, locking andunlocking of grip 40 allows for selective movement and/or rotation ofspinal implant 150 in the implant orientation.

Inserter 12 is disengaged from spinal implant 150. In some embodiments,spinal implant 150 provides height restoration between vertebral bodies,decompression, restoration of sagittal and/or coronal balance and/orresistance of subsidence into vertebral endplates. In some embodiments,surgical system 10 includes a plurality of spinal implants 150. In someembodiments, employing a plurality of spinal implants 150 can optimizethe amount of vertebral space that can be spaced apart such that thejoint spacing dimension can be preselected. The plurality of spinalimplants 150 can be oriented in a side by side engagement, spaced apartand/or staggered.

In some embodiments, surgical system 10 may comprise various instrumentsincluding the configuration of the present disclosure, such as, forexample, inserters, extenders, reducers, spreaders, distracters, blades,retractors, clamps, forceps, elevators and drills, which may bealternately sized and dimensioned, and arranged as a kit.

In some embodiments, surgical system 10 includes an agent, which may bedisposed, packed or layered within, on or about the components and/orsurfaces of surgical system 10. In some embodiments, the agent mayinclude bone growth promoting material, such as, for example, bone graftto enhance fixation with vertebrae V. The components of surgical system10 can be made of radiolucent materials such as polymers. Radiomarkersmay be included for identification under x-ray, fluoroscopy, CT or otherimaging techniques. In some embodiments, the agent may include one or aplurality of therapeutic agents and/or pharmacological agents forrelease, including sustained release, to treat, for example, pain,inflammation and degeneration. Upon completion of the procedure, thesurgical instruments, assemblies and non-implant components of surgicalsystem 10 are removed from the surgical site and the incision is closed.

In one embodiment, as shown in FIGS. 10-13, surgical system 10, similarto the systems and methods described above with regard to FIGS. 1-9,includes an inserter 312. Inserter 312 includes a body 314 that definesa longitudinal axis A2, similar to body 14 described herein. Body 314extends between an end 316 and an end 318. Body 314 includes an outersleeve 320, Outer sleeve 320 includes a handle 322, similar to handle 22described herein. Outer surface 320 includes a shaft 324, similar toshaft 24 described herein. In some embodiments, handle 322 may beassembled with shaft 324, as described herein.

Handle 322 includes a cavity 332 configured for disposal of a shaft 334,similar to shaft 34 described herein. Shaft 334 is configured to connectspinal implant 150, described herein, with inserter 312. Handle 322 isconfigured to facilitate manipulating, moving, translating and/orrotating spinal implant 150, as described herein. Handle 322 includes anactuator that includes a pivoting grip 340, similar to grip 40 describedherein. The actuator includes a knob 360, similar to knob 60 describedherein. Grip 340 includes a flange 348 configured to facilitate lockingand unlocking of grip 340 relative to handle 322, similar to flange 48described herein.

Grip 340 is configured to rotate and/or pivot relative to axis A2between a locking orientation, as shown in FIG. 11, and a non-lockingorientation, as shown in FIG. 13, of grip 340 with shaft 334. Locking ofgrip 340 resists and/or prevents translation of shaft 334, for example,such that spinal implant 150 is disposed in a selected and fixedposition relative to end 318, similar to that described herein. Rotatinggrip 340 into a non-locking orientation allows for movement and/ortranslation of shaft 334 relative to body 314 to facilitate movementand/or rotation of spinal implant 150 relative to end 318, as describedherein. Handle 322 includes a collar 350, similar to collar 50 describedherein. Collar 350 includes a cutout 352, similar to cutout 52 describedherein. Cutout 352 is configured to facilitate movement of grip 340 to anon-locking orientation, as described herein. Collar 350 is configuredto engage grip 340 for disposal in a locking orientation and anon-locking orientation relative to handle 322, In some embodiments,grip 340, similar to grip 40 described herein, is selectively disposedin the locking and non-locking orientation to selectively fix andmanipulate, move, translate, rotate and/or adjust position of spinalimplant 150 relative to end 318.

Knob 360 is rotatable, in a clockwise direction and a counter-clockwisedirection, to facilitate movement and/or translation of shaft 334 formoving and/or rotating spinal implant 150 to a selected orientation, asdescribed herein. Actuation of knob 360 causes shaft 334 to draw spinalimplant 150 into engagement with end 318 to fix spinal implant 150 withend 318 for delivery to a surgical site, as described herein.

Shaft 324 extends distally from handle 322 and includes end 318. Shaft324 includes an axial channel 396. Channel 396 is configured fordisposal of a rod 402, similar to rod 102 described herein. Rod 402extends within channel 396 and includes an end 404 and an end 406disposed adjacent end 318 and spinal implant 150 when attached withinserter 312. Rod 402 translates relative to shaft 324 and spinalimplant 150 moves and/or rotates for positioning with tissue, such as,for example, an intervertebral space, as described herein. Rod 402 isoriented with shaft 324 and engageable with a surface of spinal implant150 between a proximal position and a distal position relative to body314.

In some embodiments, rod 402 includes a biasing member, similar to coilspring 114, as described herein, that applies a biasing force to rod 402to urge rod 402 into the insertion or delivery orientation, as describedherein. End 404 includes an image guide 420 having an angle gauge 422,similar to gauge 122 described herein. Gauge 422 represents and displaysan angular measurement of the change in angle between selected relativeorientations of spinal implant 150. Gauge 422 rotates relative to shaft24, as described herein. Gauge 422 includes tracks 438, 442 configuredfor moveable disposal of a marker 444, as described herein, Gauge 422measures a change in angular orientation of spinal implant 150 betweenan orientation, for example, a delivery orientation and an orientation,for example, an implant orientation, as described herein.

With end 318 connected with spinal implant 150 in the insertion ordelivery orientation, and handle 322 and shaft 334 disposed in thelocking orientation, as described herein, spinal implant 150 is fixedwith inserter 312. End 318 is fixed with spinal implant 150 and end 406engages a surface of spinal implant 150. As spinal implant 150 ismanipulated, moved, translated and/or rotated in the implant orientationfor positioning spinal implant 150 with tissue, spinal implant 150 isengaged with rod 402 such that rod 402 translates in a proximaldirection to overcome the biasing force of the biasing member. In someembodiments, rod 402 may translate in a proximal direction and a distaldirection in the implant orientation for positioning spinal implant 150with tissue. In some embodiments, rod 402 may be manually manipulablewithout a biasing member.

In use, similar to the methods and surgical procedures employingsurgical system 10 and inserter 12, inserter 312 selectively disposesspinal implant 150 with the vertebral space between vertebrae V1, V2, asshown in FIG. 12. With end 318 connected with spinal implant 150 in theinsertion or delivery orientation, end 406 engages a surface of spinalimplant 150. Collar 350 is rotated to the non-locked orientation, asdescribed herein. Grip 340 is released for rotation to the non-lockingorientation, as shown in FIG. 13 and described herein. A pressure fitbetween ends 318, 406 is released and spinal implant 150 is movableand/or rotatable relative to end 318, 406.

Manipulation of inserter 312 causes spinal implant 150 to move and/orrotate, as described herein, into position with the vertebral spacebetween vertebrae V1, V2. As spinal implant 150 is manipulated, moved,translated and/or rotated in the implant orientation for positioningspinal implant 150 with the vertebral space between vertebrae V1, V2,spinal implant 150 is engaged with rod 402 such that rod 402 translatesin a proximal direction. Gauge 422 provides visual indicia of a measuredangle of the implant orientation for positioning spinal implant 150 withthe vertebral space between vertebrae V1, V2 relative to the insertionor delivery orientation, similar to that described herein. In someembodiments, locking and unlocking of grip 340 allows for selectivemovement and/or rotation of spinal implant 150 in the implantorientation. Inserter 312 is disengaged from spinal implant 150.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A surgical instrument comprising: a memberconnected with a spinal implant defining an axis; a first image guideconnected with the member and being oriented relative to a sensor tocommunicate a signal representative of a position of the member; asecond image guide connected with the member and being oriented torepresent an angle measuring a second orientation of the axis relativeto a first orientation; and a longitudinal element that is translatablerelative to the member, the second image guide being connected with thelongitudinal element.
 2. A surgical instrument as recited in claim 1,herein the second image guide includes indicia representing the angle.3. A surgical instrument as recited in claim 1, wherein the second imageguide includes a rotational gauge having indicia representing the angle.4. A surgical instrument as recited in claim 1, wherein the second imageguide includes indicia representing the angle, the indicia including amarker and graduated markings disposed with the member.
 5. A surgicalinstrument as recited in claim 1, wherein the first orientation includesa zero angle reference.
 6. A surgical instrument as recited in claim 1,wherein the second image guide is oriented relative to a sensor tocommunicate a signal representative of the angle.
 7. A surgicalinstrument as recited in claim 1, wherein the second image guide istranslatable and represents a rotational position of an interbodyimplant with vertebral tissue.
 8. A surgical instrument as recited inclaim 1, wherein the first image guide communicates a signalrepresentative of a three dimensional position of the spinal implant. 9.A surgical instrument as recited in claim 1, wherein the second imageguide communicates a signal representative of a position of the spinalimplant in a selected plane.
 10. A surgical instrument as recited inclaim 1, wherein the longitudinal element is fixed to the second imageguide.
 11. A surgical instrument as recited in claim 1, wherein themember includes an actuator connected with the longitudinal element thattranslates an end of the member connected with the spinal implant.
 12. Asurgical instrument as recited in claim 11, wherein the actuatorincludes a pivotable grip handle.
 13. A surgical instrument as recitedin claim 11, wherein the member includes a lock engageable with theactuator to resist and/or prevent rotation of a spinal implant connectedwith the end.
 14. A surgical instrument as recited in claim 1, whereinthe member includes an outer body that defines an axial channel fordisposal of the longitudinal element.
 15. A surgical instrument asrecited in claim 1, wherein the second image guide comprises an emittermounted with the longitudinal element.
 16. A surgical instrument asrecited in claim 1, wherein the second image guide is oriented relativeto a sensor to communicate a signal representative of the angle and thesensors communicate with a processor to generate data for display of animage from a monitor, the image representing position of the memberrelative to a body and the spinal implant relative to the member.
 17. Asurgical instrument comprising: an outer body defining an axial channeland including an image guide oriented relative to a sensor tocommunicate a signal representative of a three dimensional position ofthe outer body; an inner shaft disposed within the axial channel andbeing translatable relative to the outer body, the inner shaft beingconnected with a spinal implant defining an axis; and a rod that istranslatable relative to the inner shaft, the rod including an imageguide oriented to represent an angle measuring a second orientation ofthe axis relative to a first orientation.
 18. A surgical systemcomprising: an interbody implant defining an axis; a surgical instrumentincluding a member connectable with the interbody implant, a first imageguide connected with the member that communicates a signalrepresentative of a position of the surgical instrument, and alongitudinal element that is translatable relative to the member, thelongitudinal element being connected to a second image guide thatrepresents an angle measuring a second orientation of the axis relativeto a first orientation; and a tracking device including a sensor thatreceives the signal and communicates with a processor to generate datafor display of an image from a monitor, the image representing positionof the surgical instrument relative to a body.
 19. A surgical instrumentas recited in claim 18, wherein the second image guide includes indiciarepresenting the angle, the indicia including a marker and graduatedmarkings disposed with the surgical instrument.
 20. A surgicalinstrument as recited in claim 18, wherein the second image guide isoriented relative to a sensor to communicate a signal representative ofthe angle and the sensors communicate with the processor to generatedata for display of the image from the monitor, the image representingposition of the surgical instrument relative to the body and the spinalimplant relative to the surgical instrument.